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Eculizumab Pregnancy and Breastfeeding Warnings

Eculizumab is also known as: Soliris

Medically reviewed by Last updated on Jun 3, 2021.

Eculizumab Pregnancy Warnings

Benefit should outweigh risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk Summary: There are no data on the use of this drug in pregnant women. It is a recombinant IgG molecule (humanized anti-C5 antibody) that is expected to cross the placenta. Limited data on outcomes of pregnancies that have occurred following use of this drug in pregnant women have not identified a concern for specific adverse developmental outcomes. There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy.

-Women of childbearing potential should use adequate contraception during therapy and for up to 5 months after the last dose.

Animal studies show an increase in the rate of developmental abnormalities and fetal death at doses 2 to 8 times the recommended human dose. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Eculizumab Breastfeeding Warnings

Maternal dosages of this drug usually produce undetectable levels in breastmilk. Because it is a large protein molecule absorption is unlikely because it is probably destroyed in the infant's GI tract. No adverse effects attributable to this drug have been reported in infants who were breastfed during maternal therapy.

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-IgG is excreted into human milk, so it is expected that this drug will be present in human milk; however, antibodies in human milk do not enter the neonatal and infant circulation in substantial amounts.
-Some experts say breastfeeding should be discontinued during therapy and up to 5 months after.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Soliris (eculizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Soliris (eculizumab)." Alexion Pharmaceuticals Inc, Cheshire, CT.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.